methoxsalen (Rx) - 8MOP, Oxsoralen, Oxsoralen Ultra, Uvadex

Vitiligo
PO

20 mg with milk or food 2-4 hr before UV exposure

UV exposure: initial 15-25 min (based on skin color); add 5 min on each
subsequent exposure (qOD) up to erythema/tenderness tolerance
Topical
Apply 1% lotion to affected area 2 hr before UV exposure q3-7 days
Psoriasis
Take PO with milk or food 2 hr before UVA exposure (qOD)
Body weight guidelines

<30 kg: 10 mg
30-50 kg: 20 mg
51-65 kg: 30 mg
66-80 kg: 40 mg
81-90 kg: 50 mg
91-115 kg: 60 mg
>115 kg: 70 mg
May increase dose by 10 mg after 15 therapy sessions (do not increase any more
than this)
Cutaneous T-Cell Lymphoma
PO

Take PO with milk or food 2 hr before UVA exposure

Initial dose 0.6 mg/kg
If serum concentration <50 ng/mL, administer initial dose + 10 mg after 24 hr
Parenteral
Inject 200 mcg (10 mL) into photoactivation bag of UVAR photopheresis system
Treatment on two consecutive days q 4 weeks for a min. of 7 treatment cycles
Systemic Sclerosis (Orphan)
Uvadex indicated in conjunction with the UVAR photopheresis to treat diffuse
systemic sclerosis
Orphan indication sponsor

Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341"
Cardiac Allograft Rejection (Orphan)
Uvadex designated orphan indication for prevention of acute rejection of cardiac
allografts
Orphan indication sponsor

Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341"

Graft Versus Host Disease (Orphan)

For use in conjunction with the UVAR photopheresis system to treat GVHD
Orphan indication sponsor

Therakos, Inc; Oaklands Corporate Center, 437 Creamery Way; Exton, PA 19341
Other Information
See Manufacturer label for complete UVA therapy information

DRUG DOSAGE - INITIAL THERAPY

The methoxsalen capsules should be taken 2 hours before UVA exposure with some
food or milk according to the following table:
Patient's WeightDose
(kg)

(lbs)

(mg)

<30

<66

10

30-50 66-110

20

51-65 112-143 30

66-80 146-176 40

81-90 179-198 50

91-115 201-254 60

>115

>254

70

Additional drug dosage directions are as follows:

a. Weight Change: In the event that the weight of a patient changes during treatment
such that he/she falls into an adjacent weight range/dose category, no change in the

dose of methoxsalen is usually required. If, in the physician's opinion, however, a

weight change is sufficiently great to modify the drug dose, then an adjustment in the
time of exposure to UVA should be made.
b. Dose/Week: The number of doses per week of methoxsalen capsules will be
determined by the patient's schedule of UVA exposures. In no case should
treatments be given more often than once every other day because the full extent of
phototoxic reactions may not be evident until 48 hours after each exposure.
c. Dosage Increase: Dosage may be increased by 10 mg. after the fifteenth
treatment under the conditions outlined in section XI.B.4.b.